Clinical trial · Interventional
Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
NCT02195141CI-TRIAL-00016770unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional fraction | Radiation | — | UNRESOLVED |
| SIB | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- conventional fraction
- description
- Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily
- interventionNames
- Radiation: conventional fraction
- type
- EXPERIMENTAL
- label
- SIB
- description
- Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
- interventionNames
- Radiation: SIB
Primary outcomes (1)
- measure
- • Pathological complete remission rate (pCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge * the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound Exclusion Criteria: * metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status \> 3 * patients not deemed fit for radiotherapy, capecitabine or surgery * pregnant or lactating patients * women with child bearing potential who lack effective contraception * patients below 18 years old
References
Publications (0)
Data not yet available
No reference posted for this study.